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Medical affairs Jobs in Lowell, MA

Last updated: 15 hours ago
  • Promoted
Regulatory Affairs Manager

Regulatory Affairs Manager

BioTalentNorfolk County, MA, United States
Full-time
BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong.You will get to drive regulatory changes throughout new and existing product lines t...Show moreLast updated: 21 days ago
  • Promoted
OUTREACH MANAGER - ELDER AFFAIRS

OUTREACH MANAGER - ELDER AFFAIRS

Town of CohassetMA, United States
$32.62 hourly
Full-time
The Town of Cohasset, an active waterfront community on the South Shore, is looking for an Outreach Manager for our Elder Affairs Department. The team at the Town of Cohasset is known for being dyna...Show moreLast updated: 1 day ago
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GRADUATE STUDENT AFFAIRS COORD

GRADUATE STUDENT AFFAIRS COORD

Harvard UniversityMA, United States
$40.00 hourly
Full-time
Three or more years of experience in office administration or related field (business environment and / or customer service). Education beyond high school may count toward experience.Additional Qualif...Show moreLast updated: 1 day ago
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  • New!
Vice President / Global Head, Regulatory Affairs

Vice President / Global Head, Regulatory Affairs

CardurionBurlington, MA, US
Full-time
Vice President / Global Head, Regulatory Affairs.Vice President / Global Head, Regulatory Affairs.This role is either Hybrid in Burlington, MA or Remote. We are a clinical-stage biotechnology company di...Show moreLast updated: 15 hours ago
Medical Director (Medical Affairs)

Medical Director (Medical Affairs)

CVS HealthWork from home, MA, US
Remote
Full-time
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
Medical Director, Medical Affairs

Medical Director, Medical Affairs

VeristatMassachusetts
$150,000.00–$180,000.00 yearly
Full-time
Medical Director, Medical Affairs.The primary responsibility of the Medical Director, Medical Affairs (MD, MA) is to support the Medical Affairs department leadership in the development and impleme...Show moreLast updated: 20 days ago
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Senior Regulatory Affairs Associate / Regulatory Affairs Consultant, FSP (Genera

Senior Regulatory Affairs Associate / Regulatory Affairs Consultant, FSP (Genera

Parexel International CorporationBillerica, MA, United States
We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client an...Show moreLast updated: 30+ days ago
  • Promoted
SR GLOBAL REGULATORY AFFAIRS ECTD PUBLISHING ASSOCIATE

SR GLOBAL REGULATORY AFFAIRS ECTD PUBLISHING ASSOCIATE

Fresenius Medical CareMA, United States
Full-time
If your location allows for pay / benefit transparency, please click the link below to request further information on this position. Assists in the support of the daily operational activities within R...Show moreLast updated: 1 day ago
Medical Director, Medical Affairs

Medical Director, Medical Affairs

LifelancerMassachusetts, Massachusetts, United States
$150,000.00–$180,000.00 yearly
Remote
Full-time
Quick Apply
Medical Director, Medical Affairs.Medical Director, Medical Affairs.The primary responsibility of the Medical Director, Medical Affairs (MD, MA) is to support the Medical Affairs department leaders...Show moreLast updated: 19 days ago
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PROJECT MANAGER - US PAIN MEDICAL AFFAIRS (CONTRACT)

PROJECT MANAGER - US PAIN MEDICAL AFFAIRS (CONTRACT)

BioPharma Consulting JAD GroupMA, United States
Full-time
We are seeking highly organized and detail-oriented talent for project management support for the US Pain Medical Affairs Team. This role will be instrumental in driving operational excellence and e...Show moreLast updated: 1 day ago
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Vice President / Global Head, Regulatory Affairs

Vice President / Global Head, Regulatory Affairs

Cardurion Pharmaceuticals, IncBurlington, MA, US
Full-time
This role is either Hybrid in Burlington, MA or Remote.We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease.We have bu...Show moreLast updated: 6 days ago
  • Promoted
MANAGER, REGULATORY AFFAIRS OPERATIONS AND PROJECT MANAGEMENT

MANAGER, REGULATORY AFFAIRS OPERATIONS AND PROJECT MANAGEMENT

Deciphera PharmaceuticalsMA, United States
Full-time
The Manager of Regulatory Operations and Project Management will support the preparation and management of all activities related to regulatory submissions. Primary responsibilities will include Wor...Show moreLast updated: 7 days ago
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MEDICAL ASSISTANT

MEDICAL ASSISTANT

Carbon HealthMA, United States
Full-time
As a physician-founded and led organization, ensuring everyone has access to quality healthcare is what inspires us.The magic we've created lies in Carbon Health's custom EHR and the collaboration ...Show moreLast updated: 3 days ago
Regulatory Affairs Manager

Regulatory Affairs Manager

EPM ScientificMassachusetts
Title : Regulatory Affairs Manager.This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regula...Show moreLast updated: 30+ days ago
  • Promoted
ASSOCIATE DIRECTOR, REGULATORY AFFAIRS VACCINES CMC

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS VACCINES CMC

Takeda Pharmaceutical Company LimitedMA, United States
$149,100.00–$234,300.00 yearly
Full-time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Taked...Show moreLast updated: 3 days ago
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  • New!
VP MEDICAL AFFAIRS NEURO-RARE - REMOTE OPPORTUNITY

VP MEDICAL AFFAIRS NEURO-RARE - REMOTE OPPORTUNITY

LundbeckMA, United States
Full-time
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusi...Show moreLast updated: 17 hours ago
Vice President, Global Medical Affairs – Rare Disease

Vice President, Global Medical Affairs – Rare Disease

Fairway Consulting GroupMassachusetts
Our client is a clinical stage pharmaceuticals company.They have asked us to assist them in a search for a.Vice President, Global Medical Affairs – Rare Disease. Major tasks and responsibilities inc...Show moreLast updated: 30+ days ago
  • Promoted
ASSISTANT PROVOST FOR GRADUATE AFFAIRS, ASSOCIATE PROVOST FOR GRADUATE AFFAIRS

ASSISTANT PROVOST FOR GRADUATE AFFAIRS, ASSOCIATE PROVOST FOR GRADUATE AFFAIRS

Boston UniversityMA, United States
Full-time
Assistant Provost for Graduate Affairs.Reporting to the Associate Provost for Graduate Affairs, the Assistant Provost for Graduate Affairs oversees all matters related to university-wide graduate e...Show moreLast updated: 1 day ago
  • Promoted
Vice President and Dean for Academic Affairs

Vice President and Dean for Academic Affairs

SUNY College of OptometryMA, United States
Vice President and Dean for Academic Affairs.Position Title : Vice President and Dean for Academic Affairs.The State University of New York State College of Optometry invites nominations and applica...Show moreLast updated: 30+ days ago
VP, Quality & Regulatory Affairs

VP, Quality & Regulatory Affairs

OSI Systems, IncAndover, Massachusetts
Rapiscan Systems is an industry leader in detection technology, providing cargo and vehicle inspection systems and services for ports, borders, military, high-threat facilities, and checkpoints to ...Show moreLast updated: 30+ days ago
Regulatory Affairs Manager

Regulatory Affairs Manager

BioTalentNorfolk County, MA, United States
21 days ago
Job type
  • Full-time
Job description

BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong Regulatory Affairs Manager to join their ranks. You will get to drive regulatory changes throughout new and existing product lines to align with both FDA and EU regulations while showcasing your leadership skills to upper management.

Key Responsibilities :

  • Develop and implement regulatory strategies to facilitate timely approvals for new and existing products.
  • Manage global product registrations, licensing, and regulatory compliance across key markets.
  • Serve as the primary liaison with regulatory bodies, including the FDA, Notified Bodies, and international agencies.
  • Oversee the preparation and submission of regulatory documentation to ensure compliance with global standards.
  • Support regulatory compliance throughout the product lifecycle, including post-market surveillance activities.
  • Lead efforts to transition products from IVDD to IVDR compliance.
  • Collaborate with quality assurance teams to align regulatory and quality system requirements.
  • Guide and support the expansion of the Regulatory Affairs function, including hiring, training, and mentoring team members.
  • Manage external consultants, contractors, and regulatory support resources.
  • Foster a culture of compliance, quality, and continuous improvement across the organization.

Qualifications & Experience :

  • Minimum of 10 years of experience in regulatory affairs, particularly with Class I and Class II (IVDD / IVDR Class A / B / C) medical devices.
  • Strong knowledge of international regulatory frameworks, including MDSAP, EU IVD regulations, and global quality system standards.
  • Demonstrated expertise in preparing technical files and documentation for IVDR compliance.
  • Experience with global product registration processes across markets such as the US, Canada, Brazil, Japan, EU, Australia, and APAC.
  • Exceptional organizational, communication, and leadership skills.
  • Benefits for the Regulatory Affairs Manager

  • Hybrid work structure (3 days onsite, 2 from home).
  • Second-to-none health benefits.
  • Education assistance for continued learning.
  • New facility with an incredible culture.